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Lipid Emulsion

Intralipid vs SMOFlipid for HPN Patients with Digestive Disorders

N/A

Waitlist Available

Led By Manpreet S Mundi, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 weeks weeks

Awards & highlights

Study Summary

This trial will compare two types of lipid emulsions given to patients new to the Mayo Clinic HPN team.

Who is the study for?

This trial is for new Mayo Clinic HPN patients who can consent and expect to need parenteral nutrition for over 3 months. It's not for those under 18, pregnant or breastfeeding women, with active cancer, severe lipid metabolism issues, liver dysfunction, current infections, alcohol dependence in the last year, or known allergies to certain proteins.Check my eligibility

What is being tested?

The study compares two types of fat emulsions given through IV: Intralipid (standard treatment) and SMOFlipid. Patients are randomly assigned to one of these treatments when they start receiving care from the Mayo Clinic HPN team.See study design

What are the potential side effects?

Potential side effects may include reactions related to lipid metabolism such as elevated blood triglyceride levels. Specific side effects will depend on individual patient conditions and which lipid emulsion they receive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 weeks weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 weeks weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 weeks weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Direct Bilirubin Change is assessed

Trial Design

2Treatment groups

Active Control

Group I: IntraLipidActive Control1 Intervention

Intralipid is a lipid emulsion that contains soybean oil

Group II: SMOFLipidActive Control1 Intervention

SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,118 Total Patients Enrolled

2 Trials studying Intestinal Obstruction

12 Patients Enrolled for Intestinal Obstruction

Manpreet S Mundi, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

70 Total Patients Enrolled

Media Library

Intralipid (Lipid Emulsion) Clinical Trial Eligibility Overview. Trial Name: NCT03773237 — N/A

Intestinal Obstruction Research Study Groups: IntraLipid, SMOFLipid

Intestinal Obstruction Clinical Trial 2023: Intralipid Highlights & Side Effects. Trial Name: NCT03773237 — N/A

Intralipid (Lipid Emulsion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03773237 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are young adults eligible for this clinical research?

"In order to take part in this trial, patients must be aged 18-75. Out of the 398 similar studies, this one is in the middle in terms of age restriction. 87 studies had more lenient age requirements while 311 studies had stricter age requirements."

Answered by AI

How can I take part in this research project?

"We are looking for 100 volunteers, aged 18 to 75, that have been diagnosed with short bowel syndrome to participate in this trial. Additionally, it is a requirement that the infusion company be able to provide Smoflipid."

Answered by AI

To date, how many individuals have signed up to take part in this research?

"That is correct. The listing on clinicaltrials.gov suggests that the trial is currently ongoing and that it was originally posted on December 31st, 2018. The listing was most recently edited on June 9th, 2022. The trial is enrolling 100 patients from 1 location."

Answered by AI

Can anyone sign up for this experimental treatment program?

"Yes, this clinical trial is still looking for enrollees. Based on the information available on clinicaltrials.gov, which was last updated on June 9th, 2022, they are hoping to enroll 100 patients from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intralipid Versus SMOFlipid in HPN Patients

Manpreet S. Mundi 2018. "Intralipid Versus SMOFlipid in HPN Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03773237.

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